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Impact of Meal Composition and Alcohol Consumption on Postprandial Glycemic Control in Subjects With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03320993
Recruitment Status : Completed
First Posted : October 25, 2017
Last Update Posted : March 9, 2020
Sponsor:
Collaborators:
Hospital Francesc de Borja, Gandia, Spain
Ministerio de Economía y Competitividad, Spain
Information provided by (Responsible Party):
Jorge Bondia, Universitat Politècnica de València

Brief Summary:

Postprandial glucose control is a challenging issue in everyday diabetes care. Indeed, excessive postprandial glucose excursions are the major contributors to plasma glucose (PG) variability in subjects with type 1 diabetes (T1DM). In addition, the poor reproducibility of postprandial glucose response is burdensome for patients and healthcare professionals.

To date, the majority of prandial insulin dosing algorithms for subjects with T1DM considers only the carbohydrate (CHO) content of the meal. However, there is evidence (although with a certain degree of heterogeneity) that meal composition significantly affects postprandial glucose control, contributing to glycemic variability. Moreover, despite the high prevalence of alcohol consumption among patients with T1DM (about 30%, similar to that of the general population), data regarding its effect on the postprandial period are very limited.

This project will evaluate the effect of meal composition and alcohol consumption on postprandial glucose control in subjects with T1DM under intensive insulin treatment.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Other: Mixed meal with different macronutrient composition Not Applicable

Detailed Description:

Randomized, prospective, single-centre (Hospital Francesc de Borja, Gandia, Spain), single-blind (analysis), three -way, crossover study on type 1 diabetic subjects (n=12) under intensive insulin treatment.

Aim:

To assess the effect of mixed meal composition on postprandial glycemic control, in subjects with type 1 diabetes:

  1. Combined effect of proteins and fats
  2. Effect of alcohol consumption

Methods:

Each subject will undergo three mixed meal test studies (on three different days), with identical CHO content: On one occasion a low fat-low protein meal will be given, and on another a high fat-high protein one, both consumed with a non-alcoholic drink; on a third occasion the same high fat-high protein meal will be consumed, but this time accompanied by an equal volume of an alcoholic drink.

Patients will arrive at the research unit at 8:00 am and their blood glucose will be stabilized around 90 mg/dl before each mixed meal test. After the mixed meal, blood will be drawn every 5-30 min during a 6 hour post-prandial period to assess plasma glucose, hormones and metabolites concentration.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 3-period, 3-treatment crossover design
Masking: Single (Outcomes Assessor)
Masking Description: Data analysis will be carried out by a person not involved in the study (she/he will be blind to the study condition)
Primary Purpose: Other
Official Title: Evaluación Del Impacto de la composición Nutricional de la Ingesta y Del Consumo de Alcohol en el Control glucémico Postprandial en Pacientes Con Diabetes Tipo 1
Actual Study Start Date : October 25, 2018
Actual Primary Completion Date : January 23, 2020
Actual Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Ethanol

Arm Intervention/treatment
Active Comparator: Low Protein-Low Fat study
Subjects will receive a mixed meal with carbohydrates (70g) plus a low content of proteins and fats
Other: Mixed meal with different macronutrient composition
A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given

Experimental: High Protein-High Fat study
Subjects will receive a mixed meal with the same carbohydrates content of arm 1 (70g), but a greater amount of fats and proteins
Other: Mixed meal with different macronutrient composition
A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given

Experimental: High Protein-High Fat & alcohol study
Subjects will receive the same mixed meal of the High Protein-High Fat study plus 0,7g of alcohol per Kg of weight
Other: Mixed meal with different macronutrient composition
A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given




Primary Outcome Measures :
  1. Plasma Glucose [ Time Frame: 6 hours (plasma glucose will be measured every 5-15 minutes during the 6-hour post-prandial period of each mixed meal test). ]
    Post-prandial plasma glucose time series


Secondary Outcome Measures :
  1. AUC-PG [ Time Frame: AUC of plasma glucose will be calculated for the whole 6 hour post-prandial period, for the early 0-3 hour post-prandial period and for the late 3-6 hour post-prandial period. ]
    Area Under the Curve (AUC) of Plasma Glucose in the 0-6h, 0-3h and 3-6h post-prandial periods


Other Outcome Measures:
  1. Time in range [ Time Frame: 6 hours (time in range during the 6 hour post-prandial period) ]
    Time in acceptable glucose range (70-180 mg/dl)

  2. C Max [ Time Frame: 6 hours (maximum plasma glucose concentration during the 6 hour post-prandial period) ]
    Maximum of plasma glucose concentration

  3. T max [ Time Frame: 6 hours (Time of maximum plasma glucose concentration during the 6 hour post-prandial period) ]
    Time of Maximum plasma glucose concentration

  4. Hormones and metabolites [ Time Frame: 6 hours (plasma hormones and metabolites will be measured every 30 minutes during the 6-hour post-prandial period) ]
    Plasma concentration of free fatty acids, beta-OH-butyrate, lactate, alanine, counterregulatory hormones



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with type 1 diabetes mellitus for more than one year, aged between 18 and 60 years; on intensive insulin therapy by means of CSII (continuous subcutaneous insulin infusion) or MDI (multiple daily injections) for at least 6 months before screening; glycosylated haemoglobin of 6-8.5%; without severe chronic micro- and macroangiopathic diabetic complications and with a body mass index (BMI) between 18 and 30 kg/m2.

Exclusion Criteria:

  • Pregnancy and lactation
  • Hypoglycemia unawareness
  • Fatal or progressive disease
  • Drugs or alcohol abuse
  • HIV, active hepatitis B, active hepatitis C
  • Hepatic disease (aminotransferases AST or ALT >2 times above normal)
  • Clinically relevant microangiopathic disease, or other diseases that may interfere with participation in the study or data analysis
  • Pre-planned surgery
  • Blood donation in the previous 3 months for men and 6 months for women
  • Mental conditions that may interfere with the subject's comprehension of the aims and possible consequences of the study
  • Non-compliant subjects
  • Use of experimental medications or devices during the previous 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320993


Locations
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Spain
Hospital Francesc de Borja
Gandia, Valencia, Spain, 46072
Sponsors and Collaborators
Jorge Bondia
Hospital Francesc de Borja, Gandia, Spain
Ministerio de Economía y Competitividad, Spain
Investigators
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Principal Investigator: Paolo Rossetti, PhD Hospital Francesc de Borja, Gandia
Study Director: Jorge Bondia Company, PhD Universitat Politècnica de València
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jorge Bondia, Associate Professor, Universitat Politècnica de València
ClinicalTrials.gov Identifier: NCT03320993    
Other Study ID Numbers: DPI2016-78831-C2-1-R_alcohol
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jorge Bondia, Universitat Politècnica de València:
post-prandial glucose control
alcohol
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases